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AzTrials

Leg PainPhase 1/2NCT00221143

Stem Cell Study for Patients With Leg Ulcer/Gangrene

A Phase 1/2 study testing Autologous peripheral blood CD34 positive cell therapy in people with Leg Pain and Ulcer, run by Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan at 2 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to determine if stem cell therapy with one's own cells (autologous cells) delivered intramuscularly to one's leg with ulcer and/or gangrene due to poor blood flow will be safe and if it will relieve leg pain, increase blood flow, and/or cure the leg wound. Read more about this study

Who is it for?
Ages 20 to 80 years
Conditions the study is for
Leg Pain, Ulcer, Gangrene
What is being tested?
Autologous peripheral blood CD34 positive cell therapy
How many people
15 participants
Where
2 sitesJapan
Study dates
Nov 2003to Jan 2008
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Chronic severe CLI patients fulfilling all the following criteria are considered suitable for inclusion in the study.
  • At least 6 months since the onset of CLI (Chronic peripheral artery disease or Buerger disease)
  • Patients with luminal stenosis > 50% by leg angiography
  • Age is between 20 and 80.
  • Patients whose Rutherford's class is II-4, III-5, or III-6（Patients with rest pain or ischemic ulcer/necrosis)
  • Patients for whom angioplasty and bypass surgery are not indicated because of anatomical or procedural reasons or frequent reocclusion/ restenosis following the traditional revascularization (No option patients)
  • Patients who can give informed consent themselves in writing.

Who cannot join

  • Any one of the following exclusion criteria is sufficient to disqualify a patient from the study.
  • Left ventricular ejection fraction < 25%
  • Patients with a history of severe allergic reactions or side effects to G-CSF preparations or apheresis.
  • Less than 6 months since last episode of myocardial/cerebral infarction.
  • Patients with unstable angina, with a treatment rating of 3 in the Braunwald system, but a severity of III and a clinical rating of B or C.
  • Patients with diabetic proliferating retinopathy (new Fukuda classification BI to BV).
Show all 22Show fewer
  • Patients with malignant tumor
  • Patients with chronic rheumatoid arthritis.
  • Patients with hematological disease (leukemia, myeloproliferative disease, or myelodysplastic syndromes).
  • Patients currently suffering from or having a history of interstitial pneumonitis.
  • Patients for whom cranial MRA reveals cerebral aneurysm.
  • Patients for whom abdominal CT or ultrasonography reveals splenomegaly.
  • Patients with cirrhosis of the liver.
  • Patients who cannot discontinue Warfarin.
  • Leukocytes less than 4,000/µL or exceeding 10,000/µL.
  • Platelets less than 100,000/µL.
  • Hemoglobin less than 10 g/dL.
  • AST (GOT) exceeding 100 IU/L or ALT (GPT) exceeding 100 IU/L.
  • Patients with severe neural disorder in their legs.
  • Patients with gait disturbance for reasons other than CLI (such as sciatic neuralgia, or vasculitis), making exercise tolerance evaluation on a treadmill with stress ECG difficult.
  • Pregnant or nursing patients, those who may be pregnant, or those who plan on becoming pregnant before the end of the study period.
  • Any other reason that the Clinical Supervisors or Clinical Researchers may have for considering a case unsuitable for the study.

Trial locations and contacts

2 sites in 1 country.

Japan2 sites

  • Kobe City General Hospital

    Kobe, Hyōgo, 650-0046

  • Institute of Biomedical Research and Innovation

    Kobe, Hyōgo, 650-0047

Other trials in Japan

About this study

Official title: Phase I / II Clinical Trial Regarding Vascular Regeneration Therapy by Transplantation of Autologous Peripheral Blood Endothelial Progenitor Cells (CD34+ Cells) in No-Option Patients With Chronic Critical Limb Ischemia

The purpose of this study is to determine if stem cell therapy with one's own cells (autologous cells) delivered intramuscularly to one's leg with ulcer and/or gangrene due to poor blood flow will be safe and if it will relieve leg pain, increase blood flow, and/or cure the leg wound.

Read the detailed description

Chronic critical limb ischemia (CLI) is a progressive disease, which arises as a result of atherosclerosis or vasculitis in leg arteries. Prognosis of chronic CLI is poor, and no effective treatments have been established in patients who are not eligible for the traditional revascularization therapies such as angioplasty and bypass procedures due to the inappropriate anatomy of the leg arteries or frequent reocclusion following revascularization. Therefore, it is necessary to establish novel revascularization treatment to improve prognosis of the no-option patients. We will study the safety and clinical efficiency of vascular regeneration by means of transplantation of autologous peripheral blood endothelial progenitor cells (CD34 positive cells) in patients with chronic CLI who are not eligible for traditional revascularization treatments. The primary endpoint is the primary efficacy score identified by toe brachial blood pressure index (TBPI), absolute claudication distance (ACD) and Wong Baker's pain rating scale, while the secondary endpoints are evaluation of safety, ankle brachial blood pressure index (ABPI), percutaneous tissue oxygen pressure (TcPO2), etc.

Being tested
Autologous peripheral blood CD34 positive cell therapy
Keywords
Ulcer/ gangrene, Leg diseases, Pain, Vascular diseases, Chronic limb ischemia, Peripheral artery disease
Medical subject headings
Ulcer, Gangrene, Ischemia, Peripheral Vascular Diseases, Pain, Vascular Diseases, Peripheral Arterial Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Autologous peripheral blood CD34 positive cell therapyGenetic

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Major amputation

Secondary outcomes (1)

  1. Limb ischemia

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2005 (estimated)
  2. Study startNov 2003
  3. Study completionJan 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00221143
Sponsor's protocol ID
BRI ASO 03-01
Status last verified
Feb 2009
First submitted
13 Sep 2005
Last updated
9 Feb 2009
Results posted
No
Data monitoring committee
Yes

Publications

  • Asahara T, Kawamoto A. Endothelial progenitor cells for postnatal vasculogenesis. Am J Physiol Cell Physiol. 2004 Sep;287(3):C572-9. doi: 10.1152/ajpcell.00330.2003.

    PubMed 15308462

  • Kawamoto A, Tkebuchava T, Yamaguchi J, Nishimura H, Yoon YS, Milliken C, Uchida S, Masuo O, Iwaguro H, Ma H, Hanley A, Silver M, Kearney M, Losordo DW, Isner JM, Asahara T. Intramyocardial transplantation of autologous endothelial progenitor cells for therapeutic neovascularization of myocardial ischemia. Circulation. 2003 Jan 28;107(3):461-8. doi: 10.1161/01.cir.0000046450.89986.50.

    PubMed 12551872

  • Kawamoto A, Gwon HC, Iwaguro H, Yamaguchi JI, Uchida S, Masuda H, Silver M, Ma H, Kearney M, Isner JM, Asahara T. Therapeutic potential of ex vivo expanded endothelial progenitor cells for myocardial ischemia. Circulation. 2001 Feb 6;103(5):634-7. doi: 10.1161/01.cir.103.5.634.

    PubMed 11156872

  • Asahara T, Murohara T, Sullivan A, Silver M, van der Zee R, Li T, Witzenbichler B, Schatteman G, Isner JM. Isolation of putative progenitor endothelial cells for angiogenesis. Science. 1997 Feb 14;275(5302):964-7. doi: 10.1126/science.275.5302.964.

    PubMed 9020076

  • Takahashi T, Kalka C, Masuda H, Chen D, Silver M, Kearney M, Magner M, Isner JM, Asahara T. Ischemia- and cytokine-induced mobilization of bone marrow-derived endothelial progenitor cells for neovascularization. Nat Med. 1999 Apr;5(4):434-8. doi: 10.1038/7434.

    PubMed 10202935

  • Kalka C, Masuda H, Takahashi T, Kalka-Moll WM, Silver M, Kearney M, Li T, Isner JM, Asahara T. Transplantation of ex vivo expanded endothelial progenitor cells for therapeutic neovascularization. Proc Natl Acad Sci U S A. 2000 Mar 28;97(7):3422-7. doi: 10.1073/pnas.97.7.3422.

    PubMed 10725398

  • Kinoshita M, Fujita Y, Katayama M, Baba R, Shibakawa M, Yoshikawa K, Katakami N, Furukawa Y, Tsukie T, Nagano T, Kurimoto Y, Yamasaki K, Handa N, Okada Y, Kuronaka K, Nagata Y, Matsubara Y, Fukushima M, Asahara T, Kawamoto A. Long-term clinical outcome after intramuscular transplantation of granulocyte colony stimulating factor-mobilized CD34 positive cells in patients with critical limb ischemia. Atherosclerosis. 2012 Oct;224(2):440-5. doi: 10.1016/j.atherosclerosis.2012.07.031. Epub 2012 Jul 27.

    PubMed 22877866

  • Kawamoto A, Katayama M, Handa N, Kinoshita M, Takano H, Horii M, Sadamoto K, Yokoyama A, Yamanaka T, Onodera R, Kuroda A, Baba R, Kaneko Y, Tsukie T, Kurimoto Y, Okada Y, Kihara Y, Morioka S, Fukushima M, Asahara T. Intramuscular transplantation of G-CSF-mobilized CD34(+) cells in patients with critical limb ischemia: a phase I/IIa, multicenter, single-blinded, dose-escalation clinical trial. Stem Cells. 2009 Nov;27(11):2857-64. doi: 10.1002/stem.207.

    PubMed 19711453

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Autologous peripheral blood CD34 positive cell therapy in people with Leg Pain and Ulcer, run by Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan at 2 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Major amputation. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00221143, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2009.

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